Epithelial Ovarian Cancer Clinical Trial
Official title:
Hyperthermic Intraperitoneal Chemotherapy With Paclitaxel for the Treatment of Patients With Recurrent or Primary Advanced Ovarian Cancer : A Randomised Phase 3 Study
Randomized clinical trial to asses the efficacy of closed abdomen hyperthermia intraperitoneal chemotherapy with paclitaxel in ovarian cancer.
Randomized clinical trial performed in woman with epithelial primary ovarian cancer (stage
FIGO II, III and IV) or tumor recurrence. A cytoreductive surgery will be perform in all of
the patients include in the trial, and it will be assign at randomization:
- HIPEC-arm: cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with
paclitaxel (175 mg / m2) for 60 minutes at a temperature of 42-43º degrees; followed by
postoperative systemic IV chemotherapy with carboplatin (AUC=6) and paclitaxel (175
mg/m2) for 6 cycles.
- No HIPEC-arm: Cytoreductive surgery followed by postoperative systemic IV chemotherapy
with carboplatin (AUC=6) and paclitaxel (175 mg/m2) for 6 cycles.
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